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WO2018013947A1 - Matériau et filtre biocompatibles et hémocompatibles - Google Patents

Matériau et filtre biocompatibles et hémocompatibles Download PDF

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Publication number
WO2018013947A1
WO2018013947A1 PCT/US2017/042173 US2017042173W WO2018013947A1 WO 2018013947 A1 WO2018013947 A1 WO 2018013947A1 US 2017042173 W US2017042173 W US 2017042173W WO 2018013947 A1 WO2018013947 A1 WO 2018013947A1
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WIPO (PCT)
Prior art keywords
blood
filter
ceramic
housing
port
Prior art date
Application number
PCT/US2017/042173
Other languages
English (en)
Inventor
Andrew MENDONCA
Raman M. SUD
Morteza AHMADI
Taimoor Khan
Original Assignee
Qidni Labs, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Qidni Labs, Inc. filed Critical Qidni Labs, Inc.
Priority to US16/312,089 priority Critical patent/US20190232232A1/en
Priority to AU2017296041A priority patent/AU2017296041A1/en
Priority to EP17828546.6A priority patent/EP3484409A4/fr
Priority to CN201780043604.6A priority patent/CN109688972B/zh
Priority to JP2018568874A priority patent/JP2019521769A/ja
Priority to CA3030442A priority patent/CA3030442A1/fr
Publication of WO2018013947A1 publication Critical patent/WO2018013947A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1678—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes intracorporal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • A61M1/3661—Cannulae pertaining to extracorporeal circulation for haemodialysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/24—Dialysis ; Membrane extraction
    • B01D61/243—Dialysis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D67/00—Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
    • B01D67/0039—Inorganic membrane manufacture
    • B01D67/0067—Inorganic membrane manufacture by carbonisation or pyrolysis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
    • B01D69/04—Tubular membranes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
    • B01D69/12—Composite membranes; Ultra-thin membranes
    • B01D69/1216—Three or more layers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/02—Inorganic material
    • B01D71/021—Carbon
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/02—Inorganic material
    • B01D71/024—Oxides
    • C—CHEMISTRY; METALLURGY
    • C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
    • C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
    • C23C16/00—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes
    • C23C16/04—Coating on selected surface areas, e.g. using masks
    • C23C16/045—Coating cavities or hollow spaces, e.g. interior of tubes; Infiltration of porous substrates
    • C—CHEMISTRY; METALLURGY
    • C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
    • C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
    • C23C16/00—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes
    • C23C16/22—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes characterised by the deposition of inorganic material, other than metallic material
    • C23C16/26—Deposition of carbon only
    • C—CHEMISTRY; METALLURGY
    • C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
    • C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
    • C23C16/00—Chemical coating by decomposition of gaseous compounds, without leaving reaction products of surface material in the coating, i.e. chemical vapour deposition [CVD] processes
    • C23C16/56—After-treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0496—Urine
    • A61M2202/0498—Urea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0211—Ceramics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/04—General characteristics of the apparatus implanted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • A61M2207/10—Device therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system

Definitions

  • This application relates to materials modified to have enhanced biocompatibility and hemodynamic properties for use in blood or biological fluid filtering and dialysis applications.
  • This application relates to a medical device providing blood filtration for treatment of diseases such as end stage renal disease.
  • the system uses hemofiltration and hemodialysis for treatment.
  • the system includes a hemofilter, its casing, percutaneous and subcutaneous ports, external control components, external pump and fluid reservoirs.
  • the invention relates to the treatment of renal failure and the replacement of a human kidney.
  • the human kidney processes about 180 liters of blood every day and filters out around 2 liters of waste and extra water in the form of urine.
  • the kidneys regulate the composition of the blood by removing waste products and excess water in blood plasma.
  • Chronic kidney disease CKD is the loss of kidney function over a period ranging from months to years. Loss of kidney function can also affect other parts of the body and cause diseases such as heart failure. There is no cure for CKD but there are treatments available. Treatments manage to slow the progression of the disease, however, eventually complete kidney failure (end stage renal disease) may still occur in many patients.
  • Renal replacement therapy aims to replace the kidney with a transplant of a donated kidney, dialysis.
  • Hemodialysis and peritoneal dialysis (PD) involves long term ex vivo replacement therapy for support for renal function.
  • dialysate hemodialysis solution
  • Organ transplants is also difficult option as donors are limited and the need for the patient to take immunosuppressant medication that must be taken and the high risk of tissue rejection.
  • Ceramic materials are defined as inorganic, nonmetallic solids composed of metals and nonmetals. Common ceramics have binary compositions such as metal or metalloid oxides, nitrides, and carbides. Depending on the composition of the ceramic, the material properties may widely vary, but in general, most ceramics are strong and brittle, display high thermal and electrical non-conductivity, and are chemically inert.
  • Ceramic materials have found novel applications in many areas including filtration techniques. Certain ceramic materials have a porous microstructure, in which the pores extend through the structure of the ceramic. These structures may vary widely, and include foams, honeycombs, fibres, hollow spheres, and interconnecting rods. The porous microstructure allows for separation and filtration applications ranging between ultrafiltration (> 100 kD) to
  • a material comprises a ceramic substrate having an outer surface from which pores extend into said substrate; and a a coating over the surface layer(s) comprising a continuous layer of pyrolytic carbon which may infiltrate the substrate.
  • the coating has a thickness of about 5 nm to 50 ⁇ .
  • the ceramic substrate can be a ceramic tube filter.
  • the tube filter can comprise one or more channels.
  • the ceramic substrate can be a ceramic disk filter.
  • said substrate is formed of a ceramic material selected from the group consisting of the nitrides, carbides, or oxides of aluminum, silicon, boron, titanium, zirconium, or mixtures thereof.
  • the cut off for filtering molecules can be about 30 Da to 200,000 Da.
  • the coating can provide greater biocompatibility and hemocompatibility than the unmodified ceramic substrate material.
  • the material is adapted and configured for use in a component or for integration within a housing or for positioning to filter human or animal blood as part of the improved operation of an implantable or external blood filtration system or a clinical or bedside blood filtration system.
  • the material can be about 1 mm to 10 cm in width and 5mm to 50 cm in length.
  • a method of manufacturing comprises providing a tube filter comprising a ceramic substrate with an outer surface from which pores extend into the substrate; mounting the tube filter between two mounting disks to form a mounted filter assembly; placing the mounted filter assembly in a quartz reactor; and pyrolizing a single layer of material comprising carbon on the ceramic substrate.
  • the method comprises placing the quartz reactor in a tube furnace.
  • the mounting disks comprise a disk comprising an inner seat configured to seat an end of the ceramic tube filter; and a plurality of holes configured to allow passage of gas.
  • the inner seat can comprise a hole through the disk.
  • the pyrolizing can occur at temperatures between about 700°C and 1200°C. In some embodiments, at least 40% of the pores remain open during and after the pyrolizing.
  • the pyrolytic coating can be porous itself.
  • a hetnofiltration device comprises an outer housing; an inlet port passing through the housing configured to receive a fluid; an outlet port passing through the housing to remove flow from the device; at least one ultrafiltration ceramic membrane inside the housing; an arterial inlet chamber configured to join to a patient's artery and to the inlet port; a venous outlet chamber configured to join to a patient's vein and to the outlet port; and a cap on each end of the housing configured to seal the device and distribute flow of blood evenly to both ultrafiltration ceramic membranes.
  • the housing can comprise a biocompatible material.
  • the housing comprises at least one of titanium, stainless steel, and PEEK.
  • the patient's artery can be the iliac artery.
  • the patient's vein can be the iliac vein.
  • at least one of the ultrafiltration ceramic membranes comprise tube filters.
  • At least one of the ultrafiltration ceramic membranes can comprise a tube filter.
  • at least one of the ultrafiltration ceramic membranes comprises one or more channels.
  • the device can comprise biocompatible tubing connected to each channel.
  • at least one of the arterial inlet chamber and the venous outlet chamber comprises a vascular graft.
  • At least one of the caps can comprise a barb.
  • the device can comprise sealing plates positioned near the caps.
  • the device comprises a dialysis port configured for connection with a percutaneous port.
  • the device can comprise sealing O-rings at ends of the device.
  • the membrane can comprise a coating.
  • the coating comprises at least one of a pyrolytic carbon and a diamond like carbon.
  • the ceramic membrane can comprise a diameter of about 25 mm.
  • the ceramic membrane can comprise a length of about 100 mm.
  • the ceramic membranes comprise a pore size of about 30 Daltons to 200,000 Daltons.
  • the filter can comprise a filtration area of at least 0.1 m 2 .
  • the device can comprise a controller, valves and a pump on the outside of the patient connected to the device via a drive line.
  • the ceramic membranes are configured to hold a volume of about 200 ml.
  • the device can be connected to renal artery and renal vein of a human kidney through dialysis port(s). In some embodiments, the device is connected to renal artery and renal vein of an animal kidney through dialysis port(s). In some embodiments, the device is connected to renal artery and renal vein of a human kidney through blood port (s). The device can be connected to renal artery and renal vein of an animal kidney through blood port (s). In some embodiments, the device is connected to another device through at least one of the blood port (s) or dialysis port (s) for further processing of the filtrate or blood.
  • the device can be connected to another device through at least one of the blood port (s) or dialysis port (s), where the combination of the devices can purify blood without any need to use dialysate.
  • the device comprises two ultrafiltration ceramic membrane inside the housing.
  • the device can be configured to concentrate uremic toxins in the filtrate and keep proteins such as albumin in blood.
  • a method for filtering blood comprises implanting a filtering device in a patient, the device comprising a housing; an inlet, an outlet, and two ultrafiltration ceramic membranes inside the housing; connecting an inlet of the device to an artery of the patient; and connecting an outlet of the device to a vein of the patient.
  • the method can comprise blood entering the device at about 1 -2 psi.
  • the method comprises pumping dialysate to the device.
  • the dialysate can be pumped at a pressure of about 0.5-15 psi.
  • Figure 1 illustrates an embodiment of a support disk for a tube filter substrate.
  • Figure 2 depicts embodiments of support disks and a tube filter inside a quartz reactor (not to scale).
  • Figure 3 shows an embodiment of a tube furnace setup for coating pyrolytic carbon on ceramic tube substrate.
  • Figure 4 illustrates an embodiment of an alternate tube holders for coating the outside of tube filters.
  • Figures 5A-5B show scanning electron micrographd of the pyrolytic carbon coated filter.
  • Figure 6 depicts an embodiment of a blood filtration device implanted within a patient.
  • Figures 7-9 show various perspective views of an embodiment of a blood filtration device.
  • Figure 10 shows an embodiment of a blood filtration device with an upper portion of the housing removed.
  • Figures 1 1 A-l 1C illustrate various views of embodiments of end plates of a blood filtration device.
  • Figures 12A-D depict various views of an embodiment of an inlet or outlet of a blood filtration device.
  • Figures 1 3 A-D show various views of an embodiment of an O-Ring holder of a blood filtration device.
  • Figure 14 shows an exploded perspective view of an embodiment of a blood filtration device.
  • Figure 15 shows a graph comparing urea removal performance by the blood filtration device versus by dialysis.
  • the present application describes the modification of ceramic filters in order to increase the biocompatibility and hemocompatibility.
  • the modification is a coating of pyrolytic carbon on the ceramic, while keeping the nanopores of the filter open.
  • the ceramic can be used for filtration or dialysis applications to filter or dialyze blood or other biological fluids.
  • the ceramic can include any and all of the nitrides, carbides and oxides of aluminum, silicon, boron, titanium and zirconium, or mixtures thereof.
  • the pyrolytic carbon is made by pyrolyzing a carbon containing compound.
  • the pyrolysis occurs at temperatures between 700°C and 1200°C and can employ any carbon containing substance that is vapour in this temperature range.
  • a carrier gas can be used along with the carbon containing substance but is not necessary.
  • Small hydrocarbon compounds such as methane, ethane, propane, hexane, acetylene, ethylene, benzene, etc., are most suited to this application, but are by no means the only substances.
  • the filters can be considered as any solid material having a porous structure with pores on the order of about ⁇ ⁇ to ⁇ ⁇ , ⁇ .
  • the solid could be comprised of a single piece of material or the combining of nanoparticles or microparticles to form a single structure.
  • the ceramic may be in a tubular shape with porous walls such that the biological fluid runs through the inside and the filtrate comes out through the walls of the tube.
  • the tube may have one or many channels for the fluid to pass through.
  • the filters can be disk shaped with blood or biological fluid running on one side and the filtrate or dialysate on the other side.
  • biocompatibility of an object is directly related to its form, roughness and the material of the area in contact with bodily fluids. These properties can be under stricter restrictions when in the presence of blood due to the many clotting factors and proteins in the blood that adhere to foreign objects. Therefore, achieving 100% biocompatibility does not assure 100% hemocompatibility. In either case, there are very few materials that the body doesn't reject and even fewer that have the mechanical properties required for long term use. Carbon is one of these materials that exhibits good hemocompatibility and can be made to have the right mechanical properties based on the allotropes used. Pyrolytic carbon is a form of graphitic carbon that is highly resistant to thrombus formation and so widely employed for use in long-term medical device coating.
  • pyrolytic carbon is coated on ceramic filter to increase the biocompatibility and hemocompatibility.
  • the layer of pyrolytic carbon is from 5 nm to 50 ⁇ which varies depending on the final filter pore size required. This layer serves two purposes. Firstly, the pyrolytic carbon is very thrombus resistant so clotting does not occur easily. Secondly, the thin layer helps to smooth out the surface thereby decreasing the surface roughness and increasing biocompatibility further.
  • Ceramic filters are available in different shapes, sizes and pore sizes. For most filtration applications, disks and tube are the most common shapes used. Size is dependent on the application; though, for most biological application, the size ranges from 10-90mm diameter disks and 10-50mm diameter, 100-250mm long tubes. Ceramic disk filters are commercially available from vendors such as Sterlitech, Superior Technical Ceramics, Outotec, etc. Single- and multichannel ceramic tube filter membranes are commercially available from the vendor Atech Innovations, Tami Industries, Pall, Inopor, etc. In their current industrial form, these commercial grade materials are unsuited for the filter applications described herein. However, various embodiments of the techniques described herein may be utilized advantageously to modify the material properties of the ceramic material using one or more additional processing steps as needed and described herein.
  • ceramic tube filters are obtained that are in smaller diameter than the quartz reactor in which they will be coated.
  • Ceramic membrane filters are received as either single or multi channel tubes, with porous microstructured ceramic walls.
  • the diameter of the tube and the inner channels may vary depending on the number of inner channels.
  • the filter is prepared for pyrolytic carbon coating via mounting on two steel disk holders, approximately the same diameter as the quartz reactor (See Figure 1 ).
  • the disks can be made out of any material able to withstand the temperature at which pyrolysis is occurring. Steel is suggested due to the high melting point and relatively cheap cost.
  • Each disk 100 has a hole 102 drilled out of the centre, relatively the same diameter as the tube filters.
  • the entire 3-component setup comprising the tube filter 204 and the support disks 206 is placed into a quartz reactor.
  • the quartz reactor is then placed into a high temperature tube furnace (See Figure 3) for coating of the ceramic tube substrate with pyrolytic carbon.
  • components above are modified to provide an appropriate reactor shape, size and configuration suited to the size, shape characteristics and type of ceramic membrane being processed.
  • the methods and techniques described herein may be adapted to provide inventive coating on the outside of the tube to enhance its bio/hemocompatible qualities or characteristics.
  • the holders 400 can be modified such that there is an inner seat 402 for the tube to sit inside while large holes 404 in the rest of the disk holder allow the passage of gas (see Figure 4). If both the inside and outside of the tube is meant to be coated, then the central hole 402 could be drilled through.
  • disk filters may need to be made bio/hemocompatible.
  • disks that are slightly smaller than the diameter of the quartz reactor can be put inside the reactor as is, or on top of a steel plate/disk.
  • the reactor is setup such that gas can be introduced from either end of the quartz reactor and then exit from the opposite end. This can be switched around so that an even coating of the pyrolytic carbon can be deposited along the entire length of the tube.
  • the filter is heated in a furnace in an inert atmosphere at a rate of 5-10°C/minute until reaching the temperature of coating. This is held for 15-20 minutes for the temperature to be more uniform within the reactor.
  • the carbon-containing gas is then introduced with or without a carrier gas. Pyrolysis occurs as the gas reaches the hottest parts of the reactor and the atomized carbon deposits onto the surface of the filter. The temperature and gas inflow is held for 1 -6 hours.
  • the direction of the gas inflow is switched to the other side of the reactor.
  • the reactor is operated to reverse the flow multiple times during the coating process.
  • a computer controller is used to control the operating environment of the furnace including temperature, gas flow rates, ramp-up, ramped down cycles and the like.
  • the furnace is ramped down at a rate ⁇ 5°C/minute to 500°C in order to prevent thermal cracking. In other aspects or optionally, further ramping down can occur at a number of different rates.
  • the filter Before removal from the furnace, the filter is treated in the furnace at ambient pressure in a nitrogen gas atmosphere.
  • At least two types of gases are needed for the pyrolysis: an inert gas and a carbon- containing compound.
  • the inert gas is used to purge the reactor while heating or before the carbon-containing gas is introduced. If there is oxygen left in the reactor, the carbon would oxidize and carbonization would not occur. If the substrate is stable in air at high temperature, the inert gas purging can happen right before introduction of the carbon containing gas. Purging can also be done as the temperature is ramping up. Purging should be done with reversing the flow of gas as well so that the entire system contains no oxygen.
  • the carbon containing gas is introduced.
  • This gas can be a pure source or a mixture, though the mixture should have >10% of the carbon containing compound (by volume) so that sufficient pyrolysis can occur without leaving the system running for many hours.
  • the carrier gas if a mixture is used, should be inert so that side reactions are minimized.
  • the ideal gas flow rate can be between 100-lOOOmL/min, with larger flow rates being used for larger surface areas and larger reactor volumes. Lower flow rates can be used but coating duration will be longer unless the pressure is increased or the reactor volume is small.
  • Adhesion of the coating can also be determined using electrical impedance methods. Distilled water is flowed through the tube filters (or across disk filters), whereupon unadhered carbon is removed. This causes a change in the resistivity, which can be measured before and after subjecting the filter to water flow. Good adhesion of the carbon coating is indicated by no change in resistivity, while poor adhesion is indicated by an increase in electrical resistivity.
  • distilled water can be flowed through each of the tube filters (or across the disk filters) and the flux is measured.
  • Pig blood obtained from a butchery, can also also pumped through a coated and uncoated filter. Platelet adhesion can be measured using a differential platelet count on the blood pre- and post-filtration. This is used as a marker for the hemocompatibility with a lower differential showing better compatibility.
  • FIGs 5A-5B show a scanning electron micrograph of a nanofilter coated by pyrolytic carbon.
  • the filter has 3 layers.
  • the pyrolytic carbon eating comprises pyrolytic carbon spheres formed and melted together under high temperature. This layer can have two jobs.
  • Pyrolytic carbon has excellent hemocompatibility properties and is in use in blood contacting surfaces of devices such as heart valves and left ventricular assist device (LVAD).
  • the space between spheres act as a porous structure (mesh) blocking passage of white blood cells, red blood cells and platelets, but allows passages of plasma.
  • All uremic toxins have a molecular weight of smaller than 60,000 Da. Therefore, the filtrate contains all uremic toxins as well.
  • the middle layer is a nano filtration layer which is a porous ceramic structure comprising a combination of at least one of zirconium oxide and/or titanium oxide with pore sizes ⁇ 10nm.
  • This layer filters out proteins such as albumin (MW: 66,500 Daltons) from the plasma that has passed the pyrolytic carbon layer. The filtrate which has passed this layer would have minimal or zero amounts of albumin.
  • This layer is also hemocompatible and blocks passage of at least 90% of blood component larger than 60,000 Da
  • the third layer is a microporous ceramic support structure comprising a combination of at least zirconium oxide and/or titanium oxide.
  • This layer is hemocompatible and acts as a support for other layers of the nanofilter and maintains the nanofilter's integrity.
  • This layer is porous with pore sizes of more than 100 nm.
  • some embodiments comprise (i) pyrolytic carbon coating of ceramic filters with pores smaller than 10 nm and (ii) maintaining of the filtration properties of the substrate with ⁇ 10nm pores during and after pyrolytic carbon coating.
  • the shape and size of the pores ⁇ 10nm can change under high temperature processes needed for the pyrolytic carbon coating.
  • the current technique maintains the pore size in the coated filter in the same range as what was before coating.
  • the filter material provided by the processes described herein may be used in a number of different embodiments depending on the system where the filter will be used. A few embodiments are mentioned but are not an exhaustive list of the uses of these filters nor of the variety of size, shaped over all geometry used in any of a number of various alternative embodiments.
  • the form factor of the filter for any specific embodiment depends on and is responsive to a number of design considerations for where the filter will be employed and the overall characteristics of the filter system.
  • the treated material may be modified, sized, shaped, incorporated into a form factor or a component or components to accommodate the casing or design of a pre-existing system or a filter material adapted and configured to have a form factor for use in a system or method described in any of the following references, each of which is incorporated by reference in its entirety: WO2010088579 A2; US7540963B2; US20090131858A1 ; WO2008086477A 1 ; US20060213836A 1 ; US7048856B2; US20040124147A 1 ;
  • any of the above described systems or components described therein is modified using one or more of the techniques described herein or is replaced with a compatibly shaped and sized component having the optimized characteristics described herein for use in implanted or clinical systems that contact flowing blood within a human or animal body.
  • the filter material provided by the processes described herein may be used in a number of different embodiments depending on the system where the filter will be used.
  • the form factor of the filter component depends on a number of design considerations for how the filter will be employed and the overall characteristics of the filter system.
  • the filter material may be in a final shape for use in a filter housing without a frame.
  • the filter material may be cut, shaped, sized for use in an edge frame or a frame holder within or along the casing that is adapted and configured to engage with or received by the housing.
  • the filter material may be placed within a support frame that includes a shape, webbing, openings, apertures, indentations, or other features that will secure the filter material within the frame. The frame then includes various features or characteristics that then engage with a portion of the filter component or another housing of the filter system so that the filter material is positioned within the flow path of the filtering system.
  • a sample ceramic substrate was obtained from Atech Innovations in the form of a single channel tube-shaped alumina filter, with full outer diameter of 10 mm and inner channel diameter of 6mm.
  • the filter surface per element for the unaltered filter is 0.019/0.023m 2 .
  • the tube filter had a macroporous structure with a pore size > 10 microns, and an inner, microporous structured layer with effective pore size of 0.8 microns.
  • the substrate was heated at a rate of 10°C/min until it reached 1000°C in a nitrogen atmosphere. Nitrogen was flowed through the reactor for 10 minutes, before switching direction of the flow and purging for another 10 minutes. A mixture of 80% nitrogen and 20% methane was introduced into the reactor for 2 hours, switching direction of the gas flow halfway through. The reactor was then cooled down to 500°C at a rate of 5°C/min under nitrogen gas flow, followed by air cooling to room temperature under no gas flow.
  • Coating adhesion was checked by electrical resistivity methods. A measurement of electrical resistivity is taken across the inner coating of the tube. Water was pumped at ⁇ 3psi through the inner channel for between 1 and 4 hours. Once dried, the resistivity was measured again, with minimal change indicating good adhesion.
  • Dialysis was invented by Dr. Kolff in 1943 and it has been saving many lives since then. However, the technology has not changed much for decades. Currently, dialysis patients are generally connected to a large dialysis machine watching their blood in circulation in a plastic tube, 3 times a week for 4 hours each time with not much hope for any change in the near future. Such patients suffer emotionally and physically and they are in pain. In fact, the mortality rate of patients under dialysis is 65% in 5 years and the process is very costly. Dialysis costs about
  • the dialysis market was valued at $70 Billion in 2015 and is estimated to grow to $100 Billion by 2020.
  • the current application discloses a unique, implantable, nano filtration technology that mimics the filtration property of kidneys and is very blood friendly.
  • the nano filters disclosed herein can be so efficient that they function based on normal blood pressure. This technology can provide renal replacement therapy continuously and automatically at all times and that provides freedom and a more normal life for dialysis patients
  • Dialysis patients have high level of uremic toxin and excess water in their blood.
  • the level of uremic toxins and water in their blood peaks three times a week, right before the dialysis session. The maximum peak is usually after the weekends or holidays.
  • the filters and devices described herein can function to maintain the level of uremic toxin and excess water in the body of patients at the normal and safe level at all time, as shown in Figure 15.
  • Clinical testing has shown that the device is able to remove fluid and solutes from the animal's blood in pig animal models.
  • the present application discloses a device that has a blood inlet and a blood outlet that are connected to an artery and vein respectively.
  • the inlet draws blood into a chamber that distributes the blood into at least one tubular filter.
  • two tubular filters e.g., filters described above with respect to Figures 1 -5 are used.
  • the filters use ultrafiltration to remove waste products and excess water from the blood.
  • a vascular graft connects blood inlet to an artery and another vascular graft connects the blood outlet to the vein.
  • Ultrafiltration is a membrane based filtration process. Filters for the present invention employ the use of ultrafiltration and are used to filter out excess water, uremic toxins, and excess minerals from blood. In some embodiments, a ceramic tubular filter 009 ( Figure 10), is used as the membrane for the ultrafiltration.
  • Blood is separated from the system and sent to the renal vein while the waste is sent to the bladder.
  • the interior chamber holds and seals the filters with the help of two end plates on each side. It also consists of two small external ports that allow for dialysis to be pumped into the housing. O-rings and gaskets allow for the device to be sealed.
  • Dialysis solution can be pumped into the interior chamber percutaneously using an external pump. This allows for dialysis solution to come in contact with the exterior of the tubular filters. Valves and a controller regulate the flow and pressure of the dialysis solution. This allows for the dialysis to permeate the filters and for ion exchange to occur.
  • the device casing is constructed using biocompatible grade materials such as titanium, stainless steel or PEEK.
  • the filters are coated with a biocompatible coating such as zirconium oxide, pyrolytic carbon or diamond like carbon (DLC). Fittings and screws are also from bio-compatible materials such as medical grade stainless steel or titanium.
  • the tubing and rubber are made from medical grade materials such as PTFE, silicon and tygon.
  • the device comprises biocompatible tubing going into each membrane channel.
  • the tubing would loop in and out of the filter at each membrane. These loops can help ensure that each membrane would receive the maximum amount of blood to ensure proper ultrafiltration. It would also ensure that blood would not be exposed to any impact force or unnecessary turbulent flow.
  • the present invention utilizes ultrafiltration and hemodialysis to replicate a human kidney's function.
  • the device utilizes two multichannel tube filters to remove filtrate from the blood.
  • the filtrate contains blood components such as water, electrolytes and uremic toxins, proteins.
  • the device can remove more solutes from the blood.
  • the device comprises an outer housing 013 that acts as a collection area for the ultrafiltrate, an area where dialysis can occur and as a holder for the filters.
  • Figure 6 shows the implanted location and connections of the entire device near the iliac artery 015 and the iliac vein 016.
  • the outer housing 013 is connected at each end by a pair of plates 004, 005 ( Figures 7, 8) that both hold and seal the device.
  • the device is sealed using hemocompatible o-rings and gaskets made out of silicone and tygone and positioned at location 012 ( Figure 13).
  • the plates expose the faces of each filter to blood on both sides of the housing. They are shaped to equally distribute blood to multiple channels on the filters.
  • the blood inlet 001 can be connected to each channel in the ceramic filter through a blood distribution piece. In the blood distribution piece, blood enters through blood inlet 001 and distributes into small tubes, each connected to one filter channel. Blood enters and leaves the system at the inlet and outlet caps 003.
  • caps 003 are located each end of the housing 013 on top of the sealing plates. Both the inlet and outlet are connected to vascular grafts which allows blood to enter and leave the system. Graft 001 is connected to the inlet and graft 002 is connected to the outlet. The ends of the caps can be barbed to allow for the grafts to grip on and be secured. Blood can enter the system at a pressure of 1 to 2 psi.
  • the casing 013 can comprise medical grade 5 titanium. Titanium has a high strength, low weight and has a high corrosion resistance. It is commonly used in implantable applications such as joint replacement, spinal screws, and implantable devices. Other materials (e.g., stainless steel) are also possible. In some embodiments titanium is preferred over stainless steel due to its higher strength to weight ratio.
  • Figures 7-9 show top, side, and front perspective views, respectively, of the device.
  • Figures 7-9 show the exterior housing 013 and plates 004, 005 located at the ends of the housing.
  • Cap 003 is shown at an end of the device.
  • the cap 003 includes holes 008 which can be used to screw and seal the cap 003 to the body 013.
  • a portion of inlet graft 001 is shown at the inlet end of the device.
  • dialysis port 007 is also visible.
  • Figure 10 shows a front view of the device with the top half of the housing 013 removed, allowing visualization of the filters.
  • Blood enters the tubular membranes at one of the membrane faces 009.
  • These membranes are available in different shapes, sizes and pore sizes.
  • the pore size can have a cut off value between 30 Da to 900 kDa.
  • the membranes can be made from materials comprising zirconium oxide, T1O2 or AIO2. Other materials are also possible.
  • they can be coated with a biocompatible material such as pyrolytic carbon or a diamond like carbon.
  • the filter comprises a multichannel tubular filter. This filter configuration can advantageously maximize the active filtration area.
  • the filters can have a diameter of about 20-30 mm.
  • the filters can have a length of about 5-500 mm.
  • the pore size can be about 30 Daltons to 200,000 Daltons.
  • the active filtration area can be about 0.075-2.5 m 2 .
  • the filters have a 25 mm diameter; a length of 100 mm; a pore size of 50,000 Daltons; and an active filtration area of 0.1 m 2 .
  • the number of channels can vary as long the filter has as a filtration area of 0.1 m A 2 and a pore size of 50,000 Daltons. This pore size allows keeping most of the albumin in blood, while removing water, solutes smaller than 50,000 Daltons, urea, and creatinine.
  • Figures 1 1 A-l 1 C show front, back, and back perspective views, respectively of an embodiment of end plates 004.
  • the end plates 004 comprise a surface 010 that is configured to distribute blood to the filter.
  • Apertures 008 are shown that allow end plates 004 to be sealed to caps 003 and the housing 013.
  • Figures 12A-12D show front, back perspective, side, and front perspective views of the area around the inlet 001.
  • the outlet may have a similar configuration as that shown in Figures 12A-12D.
  • Figures 12A and 12B show the inlet 020.
  • a tapered surface 006 can function as a funnel within the cap 003 that holds blood received through the inlet 001 or awaiting exit through the outlet.
  • Figures 12C and 12D show that the cap 003 has a rounded shape, providing atraumatic surfaces for implantation and reducing risk of thrombus.
  • Screw apertures 008 can extend through cap 003, as described herein.
  • Vascular graft 001 can be connected to the inlet 020 or the outlet.
  • Figures 13A-13D show back, front, back perspective and side views of embodiments of the end plates 005.
  • a recessed portion 012 of the end plate 005 is configured to seat an O-Ring (not shown) for sealing the ends of the device.
  • the end plates 004, 005 and the cap 003 can have a sandwich construction at ends of the housing 013 of the device.
  • Figure 14 also shows filters 022 within the housing 013.
  • the cap 003 is positioned at an end of the device.
  • End plate 005 is positioned inside the cap.
  • End plate 004 is positioned inside end plate 005.
  • Order of these components may be modified in some embodiments. Additionally, in some embodiments, features of the components (e.g., funnel, O-Ring seat, etc.) may be differently distributed between the components.
  • a controller On the outside of the patient's body a controller, pump and valves will be present to regulate the intake of dialysate.
  • a flow rate of 100-800mL/min with a variable pressure allows the device to simulate dialysis treatment used in dialysis machines.
  • Dialysis solution is pumped through silicon tubing to the system at a pressure slightly higher than that of the iliac artery.
  • the pressure can range from about 0.5 to 15 psi. These parameters can help ensure the dialysis solution just barely permeates the membrane to ensure ion exchange occurs. Pressure is then lowered and dialysis solution is removed from the system. This system will remove solutes from blood.
  • Dialysate can enter the device via percutaneous port 014 that will exit the patient's body.
  • the external pump can also be used for cleaning the filters.
  • the time between dialysate entering the device and exiting the device can be a few seconds (e.g., 2-3 seconds, 1 -5 seconds, 1 -10 seconds, greater than 10 seconds, etc.).
  • the device is sutured to the patient's posterior body wall using four attachments that are present on the device and are placed on the body of the casing 013.
  • the whole device can have a length of about 85-135 mm.
  • the device can have a width of about 50-90 mm.
  • the device can have a height of about 25-55 mm.
  • the device dimensions are about 107 x 70 x 38.5 mm.
  • the vascular grafts positioned at either end of the device can be about 5-7 mm.
  • the grafts are about 6 mm, and are attached to each end of the device using clamps.
  • the grafts can sit on barbs positioned on the cap and the clamp can sit on the graft and hold it to the barb.
  • the device can comprise titanium fittings at the dialysis ports and biocompatible silicon tubing to pump dialysate into the system.
  • the filter in the device uses a volume of approximately 200 ml of blood to fill up. [00095] Data from animal blood testing is shown in Table 1 below. A filter according to this application was used for in vitro filtration of animal blood.
  • Table 2 below shows additional testing of a pyrolytic carbon filter according to this application tested in a pig animal model with no kidney function. A nephrectomy was performed on the pig model before the device was attached to the animal.
  • the collected sample contains a minimum level of albumin. Additionally, the presence of uremic toxins (urea and creatinine) in the filtrate sample is confirmed.
  • the filter used in an embodiment of a system illustrated and described in Figures 6-13 may be one configured according to one of the embodiments described with respect to Figures 1 -5.
  • a number of different form factors of the filter and/or other components of the system as in Figures 6-13 may be providing according to variations particularly as they relate to the manner the filter design and material may be used, configured or adapted for a particular use based on a particular filter design or, optionally, for a filter used in any of the other filter systems described herein.
  • the filter system described herein may be adapted to a number of different clinical and implanted configurations.
  • an implantable version of the filter system there may be embodiments that are fully implantable or partially implantable.
  • some of the components or functions of the system may remain outside of the patient's body but within communication with the implanted device using any suitable transcutaneous
  • a battery in the implanted portion may be charged transcutaneously.
  • control modules that operate in concert in terms of functionality performed by each in terms of controlling, reporting, updating or modifying control software or data streams used between external and internal components of the system or in the communications between the system and outside sources such as remote computer systems such as cloud computing systems.
  • an operating system or controller scheme used for the operation of the system may be performed in a number of suitable ways.
  • While one exemplary surgical implantation site is illustrated in Figure 6, other possible implantation sites are possible based on patient anatomy, disease state and other clinical or surgical factors.
  • features of a system adapted for implantation into a patient with impaired or compromised kidney function or aspects of the method of surgical implantation or features can be adapted given due consideration to the future plan for the patient (e.g., to receive a transplant kidney, for use with a patient in need of an artificial kidney, perhaps for an extended term).
  • the implantation site or design factors of an embodiment of the device may be modified based on specific details of the anatomical site and clinical use for the kidney failure patient and those activities that are related to the period while the patient is waiting for a donor.
  • the overall form factor of the implantable kidney takes into account a number of different considerations including, for example, the implantation site, orientation and connection points of the artificial kidney in relationship to the natural kidney or transplanted kidney and the surgical site of a partially removed or fully removed kidney.
  • the overall form factor of the implantable kidney takes into account a number of different considerations including, for example, the implantation site, orientation and connection points of the artificial kidney in relationship to the natural kidney or transplanted kidney and the surgical site of a partially removed or fully removed kidney.
  • one or more of the design features described herein including without limitation those of one of the embodiments described in co-pending, commonly assigned U.S. Provisional Patent Application Ser. No. 62/xxx,xxx, filed July 14, 2016, entitled “BIOCOMPATIBLE AND HEMOCOMPATIBLE MATERIAL AND FILTER,” (Atty Docket No. 14172-702.100) may be modified for use in or configured to provide advantages described herein into any of the components, systems, techniques and methods described in any of the following: WO2010088579A2; US7540963B2; US20090131858A1 ; WO2008086477A1 ;
  • Cianciavicchia Claudio Ronco. "Wearble artificial kidney with regeneration system” Patent: EP2281591 B 1 , each of which is incorporated herein by reference in its entirely for all purposes.
  • spatially relative terms such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under.
  • the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
  • first and second may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one
  • first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
  • a numeric value may have a value that is +/- 0.1 % of the stated value (or range of values), +/- 1 % of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc.
  • Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, then “about 10" is also disclosed.
  • any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points.

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Abstract

L'invention concerne également un matériau et filtre biocompatible et hémocompatible et adapté à des applications de filtration du sang. La biocompatibilité et l'hémocompatibilité sont obtenues par une modification d'un substrat céramique existant, dans lequel une couche de carbone pyrolytique est appliquée sur le filtre.
PCT/US2017/042173 2016-07-14 2017-07-14 Matériau et filtre biocompatibles et hémocompatibles WO2018013947A1 (fr)

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EP17828546.6A EP3484409A4 (fr) 2016-07-14 2017-07-14 Matériau et filtre biocompatibles et hémocompatibles
CN201780043604.6A CN109688972B (zh) 2016-07-14 2017-07-14 生物相容性和血液相容性材料以及过滤器
JP2018568874A JP2019521769A (ja) 2016-07-14 2017-07-14 生体適合性且つ血液適合性の材料及びフィルタ
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